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Vaccines and Bell's palsy: A narrative review
The association between vaccines and peripheral facial palsy (PFP), an issue that has been the subject of debate for many years, has been raised again following results of clinical trials assessing mRNA based COVID-19 vaccines. To review the available literature on this topic, PubMed was searched fr...
Autores principales: | , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Société française de pharmacologie et de thérapeutique. Published by Elsevier Masson SAS.
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9341208/ https://www.ncbi.nlm.nih.gov/pubmed/36038397 http://dx.doi.org/10.1016/j.therap.2022.07.009 |
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author | Bertin, Blandine Grenet, Guillaume Pizzoglio-Billaudaz, Véronique Lepelley, Marion Atzenhoffer, Marina Vial, Thierry |
author_facet | Bertin, Blandine Grenet, Guillaume Pizzoglio-Billaudaz, Véronique Lepelley, Marion Atzenhoffer, Marina Vial, Thierry |
author_sort | Bertin, Blandine |
collection | PubMed |
description | The association between vaccines and peripheral facial palsy (PFP), an issue that has been the subject of debate for many years, has been raised again following results of clinical trials assessing mRNA based COVID-19 vaccines. To review the available literature on this topic, PubMed was searched from inception until February 25, 2022. Inclusion criteria were case reports with documented rechallenge and comparative epidemiological studies. Cases of COVID-19 vaccine-induced PFP with available data on vaccine rechallenge were also identified from Vigibase until December 31, 2021. Of the 347 articles retrieved, 32 comparative epidemiological studies, 1 meta-analysis and 4 case reports met our criteria, of which 13 involved COVID-19 vaccines. Eight studies found an association between at least one vaccine and the occurrence of PFP, whereas 24 did not. Positive studies involved seasonal or pandemic H1N1 influenza vaccines administered parenterally (4 studies) or intranasally (1 study with a toxin-adjuvanted vaccine), BNT162b2, a mRNA COVID-19 vaccine (1 disproportionality analysis and 1 observed-to-expected analysis) and an inactivated virus COVID-19 vaccine (CoronaVac®) (1 study combining a case-control and an observed-to-expected approach). Strong evidence was found only for the intranasal influenza vaccine while other positive studies detected only a marginal association between PFP and vaccination. Of the four case reports with documented rechallenge, only two were positive and involved an influenza vaccine and tozinameran in one case each. In Vigibase, rechallenge was documented in 49 reports with 29 (59.2%) cases being negative and 20 (40.8%) positive. The available data did not confirm an excess risk of PFP after vaccination in most studies. Moreover, of the eight epidemiological studies suggesting a possible excess risk of PFP after any vaccine, three were disproportionality analyses and two observed-to excepted analyses, suggesting great caution should be taken when interpreting these results. |
format | Online Article Text |
id | pubmed-9341208 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | Société française de pharmacologie et de thérapeutique. Published by Elsevier Masson SAS. |
record_format | MEDLINE/PubMed |
spelling | pubmed-93412082022-08-01 Vaccines and Bell's palsy: A narrative review Bertin, Blandine Grenet, Guillaume Pizzoglio-Billaudaz, Véronique Lepelley, Marion Atzenhoffer, Marina Vial, Thierry Therapie Pharmacovigilance The association between vaccines and peripheral facial palsy (PFP), an issue that has been the subject of debate for many years, has been raised again following results of clinical trials assessing mRNA based COVID-19 vaccines. To review the available literature on this topic, PubMed was searched from inception until February 25, 2022. Inclusion criteria were case reports with documented rechallenge and comparative epidemiological studies. Cases of COVID-19 vaccine-induced PFP with available data on vaccine rechallenge were also identified from Vigibase until December 31, 2021. Of the 347 articles retrieved, 32 comparative epidemiological studies, 1 meta-analysis and 4 case reports met our criteria, of which 13 involved COVID-19 vaccines. Eight studies found an association between at least one vaccine and the occurrence of PFP, whereas 24 did not. Positive studies involved seasonal or pandemic H1N1 influenza vaccines administered parenterally (4 studies) or intranasally (1 study with a toxin-adjuvanted vaccine), BNT162b2, a mRNA COVID-19 vaccine (1 disproportionality analysis and 1 observed-to-expected analysis) and an inactivated virus COVID-19 vaccine (CoronaVac®) (1 study combining a case-control and an observed-to-expected approach). Strong evidence was found only for the intranasal influenza vaccine while other positive studies detected only a marginal association between PFP and vaccination. Of the four case reports with documented rechallenge, only two were positive and involved an influenza vaccine and tozinameran in one case each. In Vigibase, rechallenge was documented in 49 reports with 29 (59.2%) cases being negative and 20 (40.8%) positive. The available data did not confirm an excess risk of PFP after vaccination in most studies. Moreover, of the eight epidemiological studies suggesting a possible excess risk of PFP after any vaccine, three were disproportionality analyses and two observed-to excepted analyses, suggesting great caution should be taken when interpreting these results. Société française de pharmacologie et de thérapeutique. Published by Elsevier Masson SAS. 2023 2022-08-01 /pmc/articles/PMC9341208/ /pubmed/36038397 http://dx.doi.org/10.1016/j.therap.2022.07.009 Text en © 2022 Société française de pharmacologie et de thérapeutique. Published by Elsevier Masson SAS. All rights reserved. Since January 2020 Elsevier has created a COVID-19 resource centre with free information in English and Mandarin on the novel coronavirus COVID-19. The COVID-19 resource centre is hosted on Elsevier Connect, the company's public news and information website. Elsevier hereby grants permission to make all its COVID-19-related research that is available on the COVID-19 resource centre - including this research content - immediately available in PubMed Central and other publicly funded repositories, such as the WHO COVID database with rights for unrestricted research re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for free by Elsevier for as long as the COVID-19 resource centre remains active. |
spellingShingle | Pharmacovigilance Bertin, Blandine Grenet, Guillaume Pizzoglio-Billaudaz, Véronique Lepelley, Marion Atzenhoffer, Marina Vial, Thierry Vaccines and Bell's palsy: A narrative review |
title | Vaccines and Bell's palsy: A narrative review |
title_full | Vaccines and Bell's palsy: A narrative review |
title_fullStr | Vaccines and Bell's palsy: A narrative review |
title_full_unstemmed | Vaccines and Bell's palsy: A narrative review |
title_short | Vaccines and Bell's palsy: A narrative review |
title_sort | vaccines and bell's palsy: a narrative review |
topic | Pharmacovigilance |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9341208/ https://www.ncbi.nlm.nih.gov/pubmed/36038397 http://dx.doi.org/10.1016/j.therap.2022.07.009 |
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